Pediatric Project Manager II job at UtahTechnologyJobs.com in Salt Lake City

UtahTechnologyJobs.com is currently seeking to employ Pediatric Project Manager II on Wed, 11 Sep 2013 02:45:28 GMT. DESCRIPTION This is an exciting opportunity to serve as a Pediatric Project Manager II for the Pediatric Emergency Care Applied Research Network (PECARN). This position requires a self-directed person with energy, autonomy, creativity, and excellent communication skills. The Project Manager II will manage and provide oversight for all aspects of clinical research study conduct at 18 participating...

Pediatric Project Manager II

Location: Salt Lake City, Utah

Description: UtahTechnologyJobs.com is currently seeking to employ Pediatric Project Manager II right now, this job will be ordered in Utah. For detail informations about this job opportunity please give attention to these descriptions. DESCRIPTION

This is an exciting opportunity to serve as a Pediatric Project Manager II for the Pediatric Emergency Care Applied Research Network (PECARN). T! his position requires a self-directed person with energy, autonomy, creativity, and excellent communication skills. The Project Manager II will manage and provide oversight for all aspects of clinical research study conduct at 18 participating clinical sites conducting pediatric research and clinical trials.

University of Utah Job ID PRN04205B

DUTIES

  • Independently providing oversight for all aspects of study conduct, regulatory compliance, and record keeping processes
  • Assuring regulatory compliance for the Data Coordinating Center
  • Maintaining research data files and regulatory documents for all clinical trial sites
  • Identifying and creating queries to improve data capture and assists in developing methods to clarify/clean existing data
  • Reviewing site monitoring reports and discusses findings with Study Investigators and offers suggestions and solutions to problems, concerns, or recurrent trends or themes!
  • Assuring that adverse events are reported to the spo! nsor
  • Reviewing site records for accuracy regarding test article accountability
  • Developing study specific network guidelines and Standard Operating Procedures
  • Organizing study trainings and gives presentations to employees and other research coordinators on good clinical practices and study procedure implementation
  • Providing feedback on study site performance, compliance, and data quality
  • Making recommendations regarding site disciplinary actions, which may result in site monitoring visits, suspension, or discontinuation of a study site
  • Performing remote site monitoring activities independently
  • Licensed professionals may be assigned medical reviews
  • Must be able to perform the essential functions of a Level I Pediatric Project Manager
QUALIFICATIONS

Bachelor's degree in a health science field, or equivalency AND 4 years of clinical research experience that includes project management. ! Experience with human subjects research, good leadership skills, and working knowledge of FDA, ICH, and other regulatory compliance are also required. Must have excellent interpersonal and communications skills, both oral and written. Must be proficient in Microsoft Office and possess the ability to learn new software programs such as electronic data capture software.

Credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA) or other related certification is highly preferred, along with experience in the specific clinical research area.

TO APPLY, VISIT:
http://utah.peopleadmin.com/postings/25386

EQUAL EMPLOYMENT OPPORTUNITY
The University of Utah is an Affirmative Action/Equal Opportunity employer. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. The University of! Utah is committed to diversity in its workforce. Women and minorities ! are encouraged to apply. * Independently providing oversight for all aspects of study conduct, regulatory compliance, and record keeping processes
  • Assuring regulatory compliance for the Data Coordinating Center
  • Maintaining research data files and regulatory documents for all clinical trial sites
  • Identifying and creating queries to improve data capture and assists in developing methods to clarify/clean existing data
  • Reviewing site monitoring reports and discusses findings with Study Investigators and offers suggestions and solutions to problems, concerns, or recurrent trends or themes
  • Assuring that adverse events are reported to the sponsor
  • Reviewing site records for accuracy regarding test article accountability
  • Developing study specific network guidelines and Standard Operating Procedures
  • Organizing study trainings and gives presentations to employees and other research coordinators on good clinica! l practices and study procedure implementation
  • Providing feedback on study site performance, compliance, and data quality
  • Making recommendations regarding site disciplinary actions, which may result in site monitoring visits, suspension, or discontinuation of a study site
  • Performing remote site monitoring activities independently
  • Licensed professionals may be assigned medical reviews
  • Must be able to perform the essential functions of a Level I Pediatric Project Manager

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If you were eligible to this job, please give us your resume, with salary requirements and a resume to UtahTechnologyJobs.com.

Interested on this job, just click on the Apply button, you will be redirected to the official website

This job will be opened on: Wed, 11 Sep 2013 02:45:28 GMT



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